Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding

Jean-Baptiste Pretalli, Stéphanie Py, Fatimata Seydou Sall, Magali Nicolier, Karine Charrière, Thierry Chevallier, Thierry Chevallier, Thierry Chevallier, Thomas Lihoreau, Thomas Lihoreau, Thomas Lihoreau

2024

Abstract

Medical devices must comply with the safety and performance requirements of the European Medical Device Regulation. For clinical investigations, regulatory approval from competent authorities is required. ICTROUVE is a digital tool designed to help identify the clinical investigation’s category when applying to the French competent authority, the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). We aimed to evaluate ICTROUVE and to prepare a larger-scale study. This pilot study was divided in two sequences. The aim of the first was to recruit experts and to collect study synopses for which the clinical investigation’s category issued by the ANSM was known. To achieve this aim, we created and sent a questionnaire to researchers and regulatory managers via the Tech4Health network. During the second sequence, the experts had to read the synopses and assign them a clinical investigation’s category, first without and then with the help of ICTROUVE. A satisfaction questionnaire was then completed. We found a low decision agreement between experts and ANSM (39% without ICTROUVE, 51.7% with). ICTROUVE was perceived as useful, easy and quick to use. Information was gathered to facilitate a larger-scale evaluation, notably on the collection of synopses and the search for experts..

Paper Citation

in Harvard Style

Pretalli J., Py S., Seydou Sall F., Nicolier M., Charrière K., Chevallier T. and Lihoreau T. (2024). Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding. In Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed; ISBN 978-989-758-688-0, SciTePress, pages 864-871. DOI: 10.5220/0012617600003657

in Bibtex Style

@conference{clinmed24,
author={Jean-Baptiste Pretalli and Stéphanie Py and Fatimata Seydou Sall and Magali Nicolier and Karine Charrière and Thierry Chevallier and Thomas Lihoreau},
title={Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding},
booktitle={Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed},
year={2024},
pages={864-871},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0012617600003657},
isbn={978-989-758-688-0},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed
TI - Use of a Digital Positioning and Categorisation Aid for Clinical Investigations on Medical Devices: Questioning the Complexity of the Field and Harmonizing Stakeholders' Understanding
SN - 978-989-758-688-0
AU - Pretalli J.
AU - Py S.
AU - Seydou Sall F.
AU - Nicolier M.
AU - Charrière K.
AU - Chevallier T.
AU - Lihoreau T.
PY - 2024
SP - 864
EP - 871
DO - 10.5220/0012617600003657
PB - SciTePress